Status:
COMPLETED
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
Lead Sponsor:
Poxel SA
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to deter...
Eligibility Criteria
Inclusion
- Caucasian
- BMI :18.0 and 40.0 kg/m2 and weight ≥50 kg.
- Stable hepatic impairment or normal hepatic function for healthy volunteer
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (Subjects with moderate hepatic impairment may have medical findings consistent with their hepatic dysfunction)
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
- Informed consent signature
Exclusion
- Clinically relevant abnormal findings at the screening assessment
- Severe adverse reaction to any drug or sensitivity to the trial medication or its componentsClinically significant vital signs outside the acceptable range at screening
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Drug or alcohol abuse
- Positive test HIV
- Smoking more than 10 cig/day
- Participation in other clinical trials of unlicensed or prescription medicines
- Exclusion criteria for healthy volunteer
- Positive test for HBV, HBC
- eGFR less than 90 mL/min/1.73 m2
- liver diseases
- Exclusion criteria for hepatic impaired
- eGFR less than 80 mL/min/1.73 m2
- Hepatic impairment due to non liver disease
- History of hepatocellular carcinoma or acute liver disease
- CLinically significant change in liver disease status within 6 months
- ascites
- encephalopathy grade III or IV
Key Trial Info
Start Date :
November 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03802786
Start Date
November 6 2018
End Date
July 8 2019
Last Update
August 11 2020
Active Locations (1)
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1
Apex
Munich, Germany